Panel Urges FDA to Protect Patients

by | May 26, 2015 | Defective Medical Devices |

Last week, a federal panel made up of doctors, health experts, and consumer representatives concluded that the medical duodenoscopes associated with the superbug outbreak at UCLA Medical Center are unsafe as currently designed. They urged the United States Food and Drug Administration (FDA) to do more to protect patients.

exam room in a hospital

The medical devices, which have been associated with the carbapenem-resistant Enterobacteriaceae (CRE) outbreak in several patients, are currently made by three manufacturers. Of the makers, Olympus is the most dominant, with its TJF-Q160V model under scrutiny. Bacteria can become caught in an area of the device that is not accessible during cleaning and disinfection before it is used on another patient. The duodenoscopes were used in about 670,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures in 2014 alone.

Olympus and the other manufacturers were not present at last week’s panel. The panel stressed that between 10% and 30% of the scopes used in hospitals are contaminated.

Even more shocking for consumers is finding out that Olympus began selling their medical device in 2010 without seeking FDA approval. They had warned European safety regulators of the contamination problems since 2012, but did not seek U.S. FDA clearance until late 2013/early 2014.

If you or someone you know has been affected by a duodenoscope manufactured by Olympus or another manufacturer, you might be entitled to compensation. Don’t hesitate to contact an attorney to discuss your legal options today.